Post-Traumatic HeadacheTIMORNEBNCT02200185
Titrated Versus High and Low Dose Nebulized Morphine to Reduce Pain in Emergency Settings
A study testing IV titrated morphine, Low dose nebulised morphine and High dose nebulised morphine in people with Post-Traumatic Headache and Acute Pain, run by University of Monastir at 1 site in Tunisia.
Trial summary
The investigators test a different technique using morphine to improve pain relief in patient visiting the emergency department with acute trauma pain, for this we are comparing three different methods of morphine administration: intravenous titrated morphine low dose nebulized morphine and high dose nebulized morphine Read more about this study
- Who is it for?
- Ages 8 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Headache, Acute Pain
- What is being tested?
- IV titrated morphine, Low dose nebulised morphine and High dose nebulised morphine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteTunisia
- Study dates
- Apr 2012to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- patients older than 8 years and less than 50 years
- patients who consult emergency department for sever pain after an immediately trauma
Who cannot join
- Glasgow coma scale <14
- inability to cooperate
- hypotension with systolic blood pressure< 90mmhg
- bradypnea<12cpm
- SAO2<90%
- polytrauma
Show all 10Show fewer
- nasal trauma
- rhinitis
- nasal obstruction
- allergy to opioids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Nebulized Morphine Given at Two Different Doses Compared to Intravenous Morphine in Post-traumatic Acute Pain: a Randomized Controlled Double Blind Study
The investigators test a different technique using morphine to improve pain relief in patient visiting the emergency department with acute trauma pain, for this we are comparing three different methods of morphine administration:
- intravenous titrated morphine
- low dose nebulized morphine and
- high dose nebulized morphine
Read the detailed description
Trauma patients are frequent in emergency department settings, and often require urgent care.
taking care of this patients consists on taking care of their pain and then the specific treatment of their traumatic lesions.
actually, the most used medicine and most efficient one in treating pain is morphine, it's mechanism of action is by acting on receptors located on neuronal cell membranes and inhibit neurotransmitter release.
The most applied administration root of morphine is by intravenous (IV) titration or IV continuous perfusion, but until now, there is no clear recommendation concerning the superiority of this root over other administration techniques such as nebulization.
In this study we aimed to investigate the efficiency, the feasibility and the tolerance of three morphine administration roots in patients with acute traumatic pain and to clarify the most adequate one to apply in emergency department settings.
- Conditions
- Post-Traumatic Headache, Acute Pain
- Being tested
- IV titrated morphine, Low dose nebulised morphine, High dose nebulised morphine
- Keywords
- post traumatic pain, titrated morphine, nebulised morphine
- Medical subject headings
- Post-Traumatic Headache, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV titrated morphineDrug
Also called IV morphine group
Intravenous morphine : 2 mg every 5 minutes by IV root and nebulized placebo:
- SS nebulised : 5 ml SS nebulised over 10 minutes and repeated 3 times
Low dose nebulised morphineDrug
Also called Neb10
10 mg morphine in 4 ml Serum Saline(SS) nebulised over 10 minutes and repeated 3 times, and SS IV placebo : 2 ml by IV root every 5 minutes
High dose nebulised morphineDrug
Also called Neb20
20 mg morphine in 3 ml serum saline (SS) nebulised over 10 minutes and repeated 3 times, and SS IV placebo : 2 ml by IV root every 5 minutes
| Study group | Role | What they receive |
|---|---|---|
| IV titrated morphine | Placebo comparator | patient will receive 2 mg morphine each 5 min, associated to continuous nebulisation of saline serum (placebo).
Morphine administration is stopped when VAS becomes under 50% and treatment failure is defined as VAS > 50%, 30 minutes after the beginning of the protocol. Receives: Drug: IV titrated morphine |
| Low dose nebulised morphine | Experimental | patient will receive 10 mg of morphine prepared with 4 ml saline serum (SS) and nebulised with 6 l/min flow during 10 minutes.
Nebulisation will be repeated 3 times, in addition, patients receive 2 ml IV SS every 5 minutes as placebo Receives: Drug: Low dose nebulised morphine |
| High dose nebulised morphine | Experimental | patient will receive 20 mg of morphine prepared with 3 ml saline serum (SS) and nebulised with 6 l/min flow during 10 minutes.
Nebulisation will be repeated 3 times, in addition, patients receive 2 ml IV SS every 5 minutes as placebo. Receives: Drug: High dose nebulised morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain resolution
primary end point defined by the decrease in intensity pain objectified by a decline in visual analogy pain scale greater than or equal to 50% of its initial value
Measured: 30 minutes
Secondary outcomes (1)
side effects
secondary outcomes combine the occurrence of side effects requiring discontinuation of treatment such as: dizziness, dyspnea, cutaneous rush, vomiting, nausea and pruritus.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startApr 2012
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouira, University of Monastir
- Investigators
- Nouira Semir, Professor, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200185
- Sponsor's protocol ID
- TIMORNEB
- Acronym
- TIMORNEB
- Status last verified
- Nov 2014
- First submitted
- 22 Jul 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grissa MH, Boubaker H, Zorgati A, Beltaief K, Zhani W, Msolli MA, Bzeouich N, Bouida W, Boukef R, Nouira S. Efficacy and safety of nebulized morphine given at 2 different doses compared to IV titrated morphine in trauma pain. Am J Emerg Med. 2015 Nov;33(11):1557-61. doi: 10.1016/j.ajem.2015.06.014. Epub 2015 Jun 14.
PubMed 26143313
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Nebulized Morphine Given at Two Different Doses Compared to Intravenous Morphine in Post-traumatic Acute Pain: a Randomized Controlled Double Blind Study
- ClinicalTrials.gov ID
- NCT02200185
- Acronym / sponsor ID
- TIMORNEB / TIMORNEB
- Conditions
- Post-Traumatic Headache, Acute Pain
- Keywords
- post traumatic pain, titrated morphine, nebulised morphine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators test a different technique using morphine to improve pain relief in patient visiting the emergency department with acute trauma pain, for this we are comparing three different methods of morphine administration:
- intravenous titrated morphine
- low dose nebulized morphine and
- high dose nebulized morphine
Detailed description
Trauma patients are frequent in emergency department settings, and often require urgent care.
taking care of this patients consists on taking care of their pain and then the specific treatment of their traumatic lesions.
actually, the most used medicine and most efficient one in treating pain is morphine, it's mechanism of action is by acting on receptors located on neuronal cell membranes and inhibit neurotransmitter release.
The most applied administration root of morphine is by intravenous (IV) titration or IV continuous perfusion, but until now, there is no clear recommendation concerning the superiority of this root over other administration techniques such as nebulization.
In this study we aimed to investigate the efficiency, the feasibility and the tolerance of three morphine administration roots in patients with acute traumatic pain and to clarify the most adequate one to apply in emergency department settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IV titrated morphine | Placebo comparator | Drug: IV titrated morphinepatient will receive 2 mg morphine each 5 min, associated to continuous nebulisation of saline serum (placebo). Morphine administration is stopped when VAS becomes under 50% and treatment failure is defined as VAS > 50%, 30 minutes after the beginning of the protocol. |
| Low dose nebulised morphine | Experimental | Drug: Low dose nebulised morphinepatient will receive 10 mg of morphine prepared with 4 ml saline serum (SS) and nebulised with 6 l/min flow during 10 minutes. Nebulisation will be repeated 3 times, in addition, patients receive 2 ml IV SS every 5 minutes as placebo |
| High dose nebulised morphine | Experimental | Drug: High dose nebulised morphinepatient will receive 20 mg of morphine prepared with 3 ml saline serum (SS) and nebulised with 6 l/min flow during 10 minutes. Nebulisation will be repeated 3 times, in addition, patients receive 2 ml IV SS every 5 minutes as placebo. |
Who may qualify
- Ages
- 8 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- patients older than 8 years and less than 50 years
- patients who consult emergency department for sever pain after an immediately trauma
Key exclusion criteria (10 listed)
- Glasgow coma scale <14
- inability to cooperate
- hypotension with systolic blood pressure< 90mmhg
- bradypnea<12cpm
- SAO2<90%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV titrated morphineAlso: IV morphine groupIntravenous morphine : 2 mg every 5 minutes by IV root and nebulized placebo: * SS nebulised : 5 ml SS nebulised over 10 minutes and repeated 3 times | Drug | IV titrated morphine |
| Low dose nebulised morphineAlso: Neb1010 mg morphine in 4 ml Serum Saline(SS) nebulised over 10 minutes and repeated 3 times, and SS IV placebo : 2 ml by IV root every 5 minutes | Drug | Low dose nebulised morphine |
| High dose nebulised morphineAlso: Neb2020 mg morphine in 3 ml serum saline (SS) nebulised over 10 minutes and repeated 3 times, and SS IV placebo : 2 ml by IV root every 5 minutes | Drug | High dose nebulised morphine |
Primary outcome
Pain resolution
Time frame: 30 minutes
primary end point defined by the decrease in intensity pain objectified by a decline in visual analogy pain scale greater than or equal to 50% of its initial value
1 secondary outcome
side effects
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Derived from this study: PubMed 26143313Grissa MH, Boubaker H, Zorgati A, Beltaief K, Zhani W, Msolli MA, Bzeouich N, Bouida W, Boukef R, Nouira S. Efficacy and safety of nebulized morphine given at 2 different doses compared to IV titrated morphine in trauma pain. Am J Emerg Med. 2015 Nov;33(11):1557-61. doi: 10.1016/j.ajem.2015.06.014. Epub 2015 Jun 14.
- official department siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nouira Semir, Professor principal investigator
University of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV titrated morphine, Low dose nebulised morphine and High dose nebulised morphine in people with Post-Traumatic Headache and Acute Pain, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain resolution (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02200185, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014; AzTrials last refreshed its copy on 26 Oct 2026.